Accomplishments

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ORC Accomplishments February, 2013 - February, 2016

Biosafety Program (BSP)

Memberships

Continuing Corporate Member of the American Biological Safety Association (ABSA), which Certifies UH Biosafety Personnel and Keeps them Informed of Current Biosafety Issues, Professional Standards, Regulatory Initiatives, Instructional Resources, and Research Findings through Publications and Conferences

Registered Biologics Program (RBP)

Fulfilled Requirements for CDC/USDA-APHIS Certificate of Registration

Responded Successfully to On-Site Observations Made by Regulatory Agencies

Established Federally Required Occupational Health Program

Established Federally Required Initial and On-Going Suitability Assessment Program, which was Approved by the Relevant Collective Bargaining Units

Established Federally Required Respiratory Health Program

Established Federally Required Immune System Health Program (Vaccinations and Minimizing Exposure [e.g., use of appropriate PPE, Minimizing Duration of Exposure to Hazards and of Stressors to Immune System, including prolonged use of respirator])

Established Federally Required Health and Safety Risk Assessment Program

Substantively Revised Federally Required Biosecurity Plan

Substantively Revised Federally Required Biosafety Plan

Substantively Revised Federally Required Incident Response Plan

Wrote or Significantly Revised Many Standard Operating Procedures

Developed RBP Courses

Developed RBP Knowledge and Performance Tests

Developed and Implemented RBP Drills and Assessment Instruments for Drills

Developed Criteria for Inspections of RBP Facilities and Operations

Responded to Press Inquiries

Responded to Request by White House Committee on Science and Technology

Joined CDC Program to Reduce Inventory of Biomaterials Inappropriately Stored or Used or No longer of Value to the University

Participated in Monthly JBF Informational/Managerial meetings

Institutional Biosafety Committee (IBC) Administration

Administered Monthly and Special Meetings of IBC

Researched and Selected IBC Management Software

Conducted Inspections

Inspections

Inspected more than 400 Laboratories Annually for Compliance with Federal/State Regulations and University Policy

Dual Use Research of Concern (DURC)

Led Nation in Writing and Obtaining System Approval of UH DURC Policies & Procedures

Convened Inaugural Meeting of DURC Review Committee

Transporting Microorganisms and HDOA Permits

Worked with HDOA to Explore Streamlining Process for Obtaining Permits to Import Microorganisms

Modified BSBP Form

Collected Data for Annual Inventory of Microorganisms and Toxins

Waste Disposal

Established System for Proper Disposal for Sharps

Established System for Securing Autoclave Waste before Collected by Waste Management

Devised System to Prevent Theft of Potentially Hazardous Autoclave Wastes

Animal Resource Center (ARC)

AAALAC Accreditation

Contracted with Consultants to Assess Readiness of UHM to become AAALAC Accredited

Applied for AAALAC Accreditation

ARC Operations

Reduced Operational Costs of ARC Substantially

Animal Welfare Program (AWP)

Memberships

Continuing Member of the National Association For Biomedical Research (NABR), which Acts as a Liaison between UH and Federal Agencies Regulating the Care and Use of Laboratory Animals; Offers UH Analyses of Issues, Sample Responses, and Suggests Strategies; Serves as a Resource for the Media, Offering Factual Information about the Role of Animals in Biomedical Research; and Advises UH on Dealing with Concerned Citizens

Authorizations

Fulfilled Requirements for USDA Certificate of Registration

Fulfilled Requirements for OLAW Assurance

Increased Revenue by Acquiring Private Clients

IACUC Administration

Administered Monthly and Special Meetings of IACUC

In Cooperation with UVS and ARC, Planned and Presented Two Courses (IACUC 101/301), Attracting Renown Speakers and an International Audience of More than 100 Attendees

Upgraded IACUC Management Software

Post Approval Monitoring

Enhanced PAM of Facilities and Operations where Approved Vertebrate Animal Protocols are Performed

Fish Advisory Committee (FAC)

Established FAC to Inspect all Fish Teaching and Research Facilities and Operations

FAC Inspected 17 Facilities

Veterinary Services Program (VSP)

Created Questionnaire that is used by FAC during Inspections of Fish Teaching and Research Facilities

Aquatic Animal Diagnostic Laboratory (AADL)

Created AADL

Published Trifold Brochure about the AADL

Conducted Workshops for Aquatic Animal Producers

Made Presentations at Aquatic Animal Conferences

Wrote and Submitted CTSA Grant Proposal

Human Studies Program (HSP)

IRB Administration

Administered Monthly and Special Meetings of Three IRBs

Explored Possibility of Creating a Native Hawaiian IRB

Initiated a Post Approval Monitoring Program (PAM) to Confirm Protocol and Regulatory Compliance